CLASS III Drug recall · Reported 3 Apr 2019 · FDA Enforcement Report
Diclofenac Sodium Topical Solution, 1.5% w/w recalled
Ingenus Pharmaceuticals is recalling Diclofenac Sodium Topical Solution, 1.5% w/w, distributed nationwide in the US. The recall was initiated on 18 Mar 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1058-2019
- FDA event ID
- 82401
- Recalling firm
- Ingenus Pharmaceuticals, Orlando, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Mar 2019
- FDA classified
- 25 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 18 Mar 2019 | Recall initiated by company | |
| 25 Mar 2019 | Classified by FDA | +7 days |
| 3 Apr 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Which lots are affected?
Lot #: 31804, Exp 11/2019; 31911, 31917, Exp 02/2020; 32067, 32072, 32084, Exp 06/2020; 32248, Exp 10/2020
Where was it sold?
Nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ingenus Pharmaceuticals
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Flunisolide Nasal Solution recalled by Ingenus PharmaceuticalsFlunisolide | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Foam recalled by Ingenus Pharmaceuticals | Ingenus Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Leucovorin Calcium Injection, USP 500 mg*/ (10 mg/mL) Single-Dose recalled | Ingenus Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 40 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
Other Diclofenac recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Diclofenac Sodium Topical Gel recalled by Cipla USADiclofenac Sodium | Cipla USA | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 2% w/w recalledDiclofenac Sodium | Alembic Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Diclofenac Sodium Topical Solution USP, 1.5% w/w recalled | Teligent Pharma | Potency & Assay | Nationwide |